Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys
SHAG
Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States
1 other identifier
interventional
5,000
1 country
2
Brief Summary
SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Jan 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2024
CompletedStudy Start
First participant enrolled
January 15, 2024
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
December 8, 2025
December 1, 2025
2.5 years
January 10, 2024
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
HIV Incidence
HIV Incidence determined by home testing kit
12-months post-intervention and immediately post-intervention
Secondary Outcomes (3)
Self-reported HIV incidence
Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post
Proportion of Participants Testing for an STI
12-month post intervention and immediately post-intervention
Proportion of Participants having used PrEP/PEP
12-month post-Intervention and immediately post-intervention
Study Arms (2)
SHAG (Sexual Health Advocacy for Guys)
EXPERIMENTALYoung people assigned to the intervention arm will receive \~9 weeks of daily text messages that talk about healthy sexuality and ways to reduce HIV risk. After a 3 month 'quiet' period, they will receive a week of review messages. Messages are based upon the information-motivation-behavioral model of preventive behavior.
Attention-matched control
PLACEBO COMPARATORYoung people assigned to the control arm will receive \~9 weeks of daily text messages that talk about healthy lifestyle, such as self-esteem and physical exercise. After a 3 month 'quiet' period, they will receive a week of review messages.
Interventions
5 month control group program delivered via text messaging
5 month HIV prevention program delivered via text messaging
Eligibility Criteria
You may qualify if:
- have been assigned male sex at birth and currently have a cisgender identity;
- be aged 13-22 years old;
- have had anal sex in the past 12 months;
- be English-speaking;
- exclusively own a cell phone with an unlimited text messaging plan and intend to have the same cell phone number for the next 6 months;
- have Internet access to complete online surveys;
- provide informed assent for those under 18, and consent for those 18 years of age and older, including a capacity to consent and a positive self-safety assessment;
- Willing to take an OraQuick home test to confirm HIV negativity for youth who are 19-20 years of age or 18 years old and graduated high school. If they agree to do the test but do not upload a photo of their result, they will be eligible if they self-report a negative sero-status. Youth 18 years old who have not graduated high school, and 13-17 years of age will be asked to take a home test. If they determine that they cannot do so safely, they will be allowed to self-report their sero-status; and
- not currently enrolled in another HIV prevention program; or
- know anyone already enrolled in the RCT.
You may not qualify if:
- Being HIV positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for Innovative Public Health Research
San Clemente, California, 92672-6745, United States
Center for Innovative Public Health Research
San Clemente, California, 92672, United States
Related Publications (1)
Ybarra ML, Feaster DJ, Garofalo R, Bull S. Sexual Health Advocacy for Guys (SHAG): a randomized trial of the impact of a text-messaging program on HIV incidence and STI testing among a national sample of sexual minority cisgender adolescent and young adult men. Trials. 2025 Jan 6;26(1):9. doi: 10.1186/s13063-024-08540-9.
PMID: 39762976DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Control group content is written to affect an experience as if one were in the intervention group.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2024
First Posted
January 30, 2024
Study Start
January 15, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
December 8, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available starting 12 months after the grant ends.
- Access Criteria
- * Data access requires sponsorship by an Institution on behalf of the prospective recipient. * Requester must provide documentation of local IRB approval * Requester agrees to make results of studies using the data available to the larger scientific community * Requester must provide a letter of collaboration with the primary study investigator * Use of the data is limited to not-for-profit organizations * Use of the data is limited to health purposes
Individual-level de-identified data will be made available through controlled access.